MedTrace Logo

Tolerability and Risk of Adverse Events With a Probiotic Supplement

NCT03728868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-25

No results posted yet for this study

Summary

The butyrate-producing bacterium Faecalibacterium prausnitzii is abundant in the human bowel and can make up to 5% of the gastrointestinal flora in healthy individuals. A reduced presence of it has been associated with an imbalance in the gastrointestinal flora of metabolic syndromes such as type 2 diabetes, fat liver, and in inflammatory bowel disease.

The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with F.prausnitzii (combined with D. piger) once a day for 8 consecutive weeks is tolerated compared to placebo and if it can affect the metabolism in a positive way.

Conditions

  • Healthy Individuals

Interventions

DIETARY_SUPPLEMENT

Placebo

Dietary supplementation with placebo once a day for 8 consecutive weeks

DIETARY_SUPPLEMENT

High dose F. prausnitzii and D. piger

Dietary supplementation with high dose F. prausnitzii and D. piger once a day for 8 consecutive weeks

DIETARY_SUPPLEMENT

Low dose F. prausnitzii and D. piger

Dietary supplementation with low dose F. prausnitzii and D. piger once a day for 8 consecutive weeks

Sponsors & Collaborators

  • MetaboGen AB

    collaborator INDUSTRY

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Mattias Lorenzon, MD, PhD · Dept Geriatrics, Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728868 on ClinicalTrials.gov